The impact of comorbidity on health-related quality of life in elderly patients with chronic myeloid leukemia.

The primary objective of this study was to investigate whether the presence of comorbidities was associated with a lower health-related quality of life (HRQOL) in elderly patients with chronic myeloid leukemia (CML). A sample of 174 CML patients aged 60 years or above was analyzed. HRQOL was assessed with the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36). A number of pre-selected sociodemographic and disease-related factors were considered as potential confounding factors for the association between comorbidity and HRQOL. Mean age of the 174 patients analyzed was 70 years (range 60-87 years) and 55 % were male. Overall, 111 patients (64 %) reported at least one comorbidity. Analysis stratified by age group category showed a greater proportion of patients with comorbidities in the older sub-group population (≥70 years) compared to younger patients (60 to 69 years). Differences in HRQOL outcomes between patients with no comorbidity at all and those with two or more comorbid conditions were at least twice the magnitude of a clinically meaningful difference in all the physical and mental health scales of the SF-36. In multivariate analysis, after adjusting for key confounding factors, the following scales were significantly lower in those with comorbidity: general health (p < 0.001), bodily pain (p < 0.001), physical functioning (p = 0.002), and vitality (p = 0.002). Assessing comorbidity in elderly patients with CML is important to facilitate identification of those most in need of HRQOL improvements.

Managing chronic myeloid leukaemia in the elderly with intermittent imatinib treatment.

The aim of this study was to investigate the effects of a non-standard, intermittent imatinib treatment in elderly patients with Philadelphia-positive chronic myeloid leukaemia and to answer the question on which dose should be used once a stable optimal response has been achieved. Seventy-six patients aged ⩾65 years in optimal and stable response with ⩾2 years of standard imatinib treatment were enrolled in a study testing a regimen of intermittent imatinib (INTERIM; 1-month on and 1-month off). With a minimum follow-up of 6 years, 16/76 patients (21%) have lost complete cytogenetic response (CCyR) and major molecular response (MMR), and 16 patients (21%) have lost MMR only. All these patients were given imatinib again, the same dose, on the standard schedule and achieved again CCyR and MMR or an even deeper molecular response. The probability of remaining on INTERIM at 6 years was 48% (95% confidence interval 35-59%). Nine patients died in remission. No progressions were recorded. Side effects of continuous treatment were reduced by 50%. In optimal and stable responders, a policy of intermittent imatinib treatment is feasible, is successful in about 50% of patients and is safe, as all the patients who relapsed could be brought back to optimal response.

Response to low-dose oral methotrexate and prednisone in two patients with angio-immunoblastic lymphadenopathy-type T-cell lymphoma.

INTRODUCTION: AILD-type T-cell lymphoma is characterized by very poor prognosis in most patients and the response rate to conventional chemotherapy is unsatisfactory. MATERIALS AND METHODS: Two patients (a 65 year old female and a 67 year old male) with AILD-type lymphoma who did not respond to conventional treatment with steroids or aggressive chemotherapy were treated with Methotrexate and Prednisone. Both patients received a weekly dose of MTX (10 mg/m(2)) that was administered orally in combination with PDN at an initial dose (15 mg/day), given on a daily basis. RESULTS: Both patients responded rapidly showing marked improvement with no major side effects. Complete clinical remission was recorded in the two patients who were treated with this combination after conventional chemotherapy had failed to produce any improvement. CONCLUSION: Our observations in two patients with refractory/relapsed AILD-type lymphoma who were given low-dose oral MTX as salvage treatment, suggest that this agent has immunosuppressive effects that can be beneficial for treating patients with AILD-type T-cell lymphoma. Pilot clinical trials are needed to verify its efficacy in this setting.

Factor V Leiden and prothrombin gene mutation in inflammatory bowel disease in a Mediterranean area.

BACKGROUND: Thromboembolism has been reported to be associated with inflammatory bowel disease. AIM: To evaluate the association of factor V Leiden and prothrombin gene mutation with inflammatory bowel disease in a population of patients with thromboembolic events and inflammatory bowel disease and in a control population of patients with inflammatory bowel disease without thromboembolic events. PATIENTS AND METHODS: A series of 18 patients with inflammatory bowel disease and a history of arterial or venous thrombosis and 45 patients with inflammatory bowel disease without thromboembolic events were evaluated for the presence of factor V Leiden and prothrombin gene mutation. Frequency of gene mutation was compared with its occurrence in 100 healthy controls. RESULTS: One patient with inflammatory bowel disease without thromboembolic events was heterozygous for factor V Leiden mutation. whereas no patient with a thromboembolic event had factor V Leiden mutation. No patients (either cases or controls) had prothrombin gene mutation. In the healthy population the frequency of factor V Leiden and prothrombin mutation was 5% and 2%, respectively. CONCLUSIONS: Data emerging from the present study do not support any role of factor V Leiden and prothrombin gene mutation as the cause of thromboembolism in inflammatory bowel disease.

Clinical spectrum of "unstable angina".

In order to determine the natural evolution of different clinical types of "unstable angina", 167 patients were included in a prospective study. After angiography, 11 (6.5%) were excluded because they had no significant coronary lesions. The remaining 156 were sorted into different groups according to their clinical characteristics and were followed up for a period of 24 months at least. After that follow-up period, mortality and incidence of acute myocardial infarction (AMI) were as follows: angina of recent onset (Class III--IV NYHA): 8.5% (3/35) and 34.2% (12/35). Progressive angina: 7.4% (2/27) and 7.4% (2/27). Intermediate syndrome: 41.6% (10/24) and 37.5% (9/24). Prinzmetal's angina: 10% (1/10) and 10% (1/10). Post acute myocardial infarction angina: 35% (7/20) and 10% (2/20). Acute persistent ischemia: 2.5% (1/40) and 20% (8/40). Comparison of these figures pointed out significant differences (p less than 0.001 for mortality and p less than 0.03 for AMI incidence respectively). We conclude that it is clinically possible to identify different groups within the so-called unstable angina. Such a division not only allows for the creation of more homogeneous groups, but it contributes to a more rational therapeutic approach and also permits identification of high risk prodromes of greater complications, such as myocardial infarction or sudden death.

[High-dose immunoglobulins in immune thrombocytopenic purpura]. / Immunoglobuline ad alte dosi nella porpora trombocitopenica immune.

Twenty-four patients with immune thrombocytopenic purpura (ITP) were treated with high doses of intravenous immunoglobulin (Ig). Increase in platelets was observed in all the patients. The maximum value was reached between the seventh and the twelfth day of treatment. The mean number of platelets was 18 x 10(9)/l before the treatment and 150 x 10(9)/l after the treatment. The effect was transient; in fact, a fall in the platelets was observed after 18 days of treatment. Our study confirms that high doses Ig is an effective treatment of ITP, but the high cost and the temporary effect limit its use only in those cases in which other treatments are ineffective or contraindicated.

Chronic fatigue is the most important factor limiting health-related quality of life of chronic myeloid leukemia patients treated with imatinib.

Health-related quality of life (HRQOL) is an important goal of therapy for chronic myeloid leukemia (CML) patients treated with current molecular-targeted therapies. The main objective of this study was to investigate factors associated with long-term HRQOL outcomes of CML patients receiving imatinib. Analysis was performed on 422 CML patients recruited in an observational multicenter study. HRQOL was assessed with the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36). Key socio-demographic and clinical data were investigated for their association with HRQOL outcomes. Chronic fatigue and social support were also investigated. Univariate and multivariate linear regression analyses were used to identify independent factors associated with HRQOL outcomes. Fatigue was the only variable showing an independent and consistent association across all physical and mental HRQOL outcomes (P<0.01). Differences between patients reporting low versus high fatigue levels were more than eight and seven times the magnitude of a clinically meaningful difference, respectively, for the role physical (Δ=70 points) and emotional scale (Δ=63 points) of the SF-36. Fatigue did not occur as an isolated symptom and was most highly correlated with musculoskeletal pain (r=0.511; P≤0.001) and muscular cramps (r=0.448; P≤0.001). Chronic fatigue is the major factor limiting HRQOL of CML patients receiving imatinib.

Alpha-interferon in polycythemia vera and essential thrombocythemia.

Twenty-one patients with chronic myeloproliferative disorders, eleven with polycythemia vera (PV) and ten with essential thrombocythemia (ET), were treated with small doses of alpha-2a interferon (IFN). The median follow-up was, respectively, 10.8 months (range 4-22) for PV and 8.11 months (range 4-16) for ET. Six patients with PV and five with ET had been previously treated with conventional cytotoxic drugs, while the remaining patients were newly diagnosed. In four patients with PV we observed a durable normal hematocrit level (PCV less than 0.48) and a reduction of platelet count and spleen size within 4-8 weeks of treatment. Three patients achieved moderate disease control. In the others the disease remained substantially unchanged. Five out of nine evaluable patients with ET showed complete response (CR) within six weeks, one patient had a partial response (PR) and three no response (NR). In one patient with ET the IFN therapy was stopped after twelve days because neurological side effects were observed. All the other patients tolerated long-term treatment very well.

Antihypertensive and hemodynamic effects of slow-release nicardipine.

The antihypertensive efficacy, the hemodynamic effects and the tolerability of a new slow-release nicardipine (SR-Nic) formulation, capsules containing 40 mg of active drug, have been tested in a randomized, double-blind placebo (P)-controlled study. Thirty mild-to-moderate essential hypertensives were enrolled and after a one-week single-blind placebo run-in period randomly allocated to SR-Nic or P twice-day for six weeks. Blood pressure (BP) was measured after 1, 2, 4 and 6 weeks of treatment. Hemodynamic parameters were evaluated non-invasively by the impedance cardiography technique, using the Noninvasive Continuous Cardiac Output Monitor (NNCOM 3, BoMed Medical Manufacturing Ltd), after 2 and 4 weeks of treatment. All the determinations were made before the morning administration, i.e., 12-14 h after evening intake of SR-Nic or P. The blood pressure (p less than .01) and hemodynamic response (p less than .01 for the systemic vascular resistances) in the SR-Nic group significantly differed from those in the P group. At the end of the study, there were decreases in mean systolic/diastolic BP values of 17/12 in the sitting and of 18/12 mmHg in the standing position in the SR-Nic group; in the P group, the changes were +2/-2 in the sitting and +2/-1 mmHg in the standing position. Systemic vascular resistances were reduced by 17.3% in the SR-Nic and by 1.9% in the P group after 4 weeks of treatment.(ABSTRACT TRUNCATED AT 250 WORDS)

Double-blind comparison of once-daily bopindolol and atenolol for mild-to-moderate hypertension.

In order to compare the medium term antihypertensive effectiveness and tolerability of atenolol with those of bopindolol (LT 31-200), a new non-selective beta-blocker with slight PAA (partial agonist activity), a randomized double-blind study was performed. Thirty-one outpatients with mild-to-moderate essential hypertension (WHO stage I-II) were enrolled and after a placebo run-in randomly allocated to bopindolol (1 to 4 mg/day) or atenolol (50 to 200 mg/day). The dose was titrated according to the individual pressor responses, and thereafter it was kept constant until the end of the treatment (12 weeks). Both drugs induced statistically significant decreases in SBP, DBP and HR, both in resting conditions and during an ergometric test. Accordingly, most patients achieved the main goal of the therapy, i.e., supDBP less than or equal to 90 mmHg, 11/15 (74%) with bopindolol versus 8/13 (62%) with atenolol. There were no significant differences between the effects of the two compounds. Resting airway resistance (expressed as Peak Expiratory Flow) was not influenced by the treatments. The antihypertensive efficacy was still evident after 12 months in 8 patients who were evaluated for non-comparative long-term effectiveness of bopindolol monotherapy, and improvements in plasma lipid profiles were also observed. Side effects were relatively mild and transient, with two patients in the atenolol group discontinuing therapy (one for inefficacy and one because of undesirable reactions) and one dropped out in the bopindolol group (late evidence of not fulfilling inclusion criteria).(ABSTRACT TRUNCATED AT 250 WORDS)